Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Voxzogo®️ (vosoritide) - Direct communication with healthcare professionals on Voxzogo®️ (vosoritide)

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Direct communication with healthcare professionals on Voxzogo®️ (vosoritide)

Voxzogo® (vosoritide): change to administration syringe and needle leading to product administration in Units (U) instead of mL.

Summary

  • From July 2023, Voxzogo co-packs will contain new solvent needles and new administration syringes due to supply chain reasons.  
  • The new solvent needle has an alternative safety mechanism with an activated safety shield cover (see Table 1).
  • The new administration syringe has Units (U) graduation markings( typically used for insulin products and sometimes referred to as Insulin Units) instead of mL graduation markings (see Table 1).  
  • It is important that you explain to your patient or the caregiver the recommended dose to be delivered with the new syringe, as the units of measure are not 1:1. For example, 0.1 mL is equivalent to 10 U. Please see Table 2 for the conversion of single dose volumes from mL to U.
  • There are no changes to the Voxzogo dosage or volume. Recommendations for use remain unchanged.
  • The product information has been amended to reflect the use of new needles and syringes.


Published on: 04 September 2023

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